Analysis and reporting of vaccine adverse events data in Australia

In Australia, monitoring of adverse events following immunisation (AEFI) is done by national passive surveillance (i.e. initiated by the ‘reporter’). This is carried out through voluntary reporting to the Office of Product Review (OPR) of the Therapeutic Goods Administration (TGA).

Reports of adverse events can be made by immunisation providers, parents, pharmaceutical companies or other parties. In all states and territories (except Tasmania) it is preferable that reporting of AEFI for NIP vaccines is done via the local health authority who then transmits the adverse event report to the TGA. For more information, check with your state/territory health department or with the TGA.

Reported AEFI may be either causally related to, or coincidental with, an immunisation. Surveillance of AEFI can include reports of well-recognised adverse events associated with particular vaccines, as well as events not previously associated with a vaccine. It can provide signals or generate hypotheses about previously unknown AEFI. However, other more rigorous scientific techniques are required before causality can be determined.

Since August 2012, the Database of Adverse Event Notifications (DAEN) has been available on the TGA website. The database is searchable and contains reports of all adverse event reports for medicines (including vaccines). These reports come from a wide range of sources, including from members of the public, GPs, other health professionals and from the therapeutic goods industry.

For both medicines and vaccines, individual reported adverse events are reviewed by the TGA. AEFI reports for vaccines are then passed in de-identified form to NCIRS for various analyses, including the preparation of regular national AEFI surveillance reports, national immunisation program evaluations, reports to the Australian Technical Advisory Group on Immunisation (ATAGI) and ad hoc analyses.

Annual AEFI surveillance reports have been prepared by NCIRS in collaboration with the TGA and published in Communicable Diseases Intelligence since 2003. These reports contain valuable information such as the rate at which an adverse event following vaccination is reported. They also contain information about serious adverse events and deaths that are reported to have occurred following a vaccine. The most recent annual report (containing information on all reported AEFI) is: